Tokyo, July 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055078) titled 'Evaluation of the Effects of Test Food Consumption on Performance' on July 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To scientifically evaluate the effects of test food consumption on performance in study subjects aged 25 to 49 years who have poor sleep quality and persistent physical fatigue.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food (3 tablets a day) for 8 weeks
Interventions/Control_2 - Consumption of the placebo food (3 tablets a day) for 8 weeks
Eligibility:
Age-lower limit - 25
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Men and women aged 25 to 49 years at the time of consent.
2. Subjects who have a habit of exercising for more than 5 hours per week.
3. Subjects who have perceived poor sleep quality for more than one month prior to consent acquisition.
4. Subjects who have perceived physical fatigue for more than one month prior to consent acquisition.
5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - 1. Subjects currently undergoing medication or outpatient treatment for any serious disease, or those with a history of serious disease.
2. Subjects who cannot maintain their exercise habits and dietary habits from before the study during the trial period.
3. Subjects who are prone to diarrhea or have a weak stomach when consuming dairy products or foods containing lactic acid bacteria in excess.
4. Subjects with extremely irregular lifestyle habits, such as diet and sleep.
5. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
6. Females who are pregnant or lactating, and females who could become pregnant during trial period.
7. Subjects with allergies to medications and/or food.
8. Subjects deemed unsuitable for participation in the trial by the study representative or the principal investigator.
Target Size - 50
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 06 Month 24 Day
Date of IRB - 2024 Year 06 Month 21 Day
Anticipated trial start date - 2024 Year 07 Month 28 Day
Last follow-up date - 2024 Year 11 Month 25 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062565
Disclaimer: Curated by HT Syndication.
